BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*RH REG SKIN STAPLER

    MDR report key: 3143383 · Received June 3, 2013

    Report

    Report Number
    3005075853-2013-02763
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDT
    PMA / PMN Number
    K833357
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT:(B)(4) 2013. INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS SHOWED THAT ONE PRR35 INSTRUMENT WAS RETURNED NON-FUNCTIONAL DUE TO JAMMED STAPLES IN THE CARTRIDGE NOSE, CAUSING THE STAPLES NOT TO PROPERLY ADVANCE. NO FUNCTIONAL TEST WAS PERFORMED. AS NO CONCLUSION COULD BE REACHED ON WHAT CAUSED THE STAPLES TO BECOME JAMMED, IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORTHO PROCEDURE THE STAPLES DROPPED EASILY WHILE USING AND COULD NOT CLOSE COMPLETELY. A NEW LIKE DEVICE WAS USED TO COMPLETE THE CASE. .NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244568 PROXIMATE*RH REG SKIN STAPLER REMOVABLE (SKIN) GDT ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1